The FDA released a draft guidance requiring that generic version of abuse-deterrent opioids are at least as difficult to manipulate as the original med, as it ramps up its efforts again the prescription medication abuse epidemic, which has been implicated in the startling and unprecedented rise of the death rate among middle-aged white Americans.
The Regulatory Affairs Professional Society reports that the in vitro tests will follow a "tier-based" approach, "starting with simple and gentle manipulations of the product during in vitro studies and progressing to more destructive mechanical and chemical manipulations until [the reference] product's abuse deterrence is defeated or compromised, or the [generic] product is shown to be less abuse-deterrent," according to the guidance, entitled "General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products."
Note that the generic drug is not required to have the same formulation as the so-called reference product that it is imitating.
The FDA issued an analogous guidance for brand-name drugs and drug makers, in which it named 6 types of abuse-deterring technology, including physical or chemical barriers, aversion techniques such as bad smells, delivery systems like sustained release patches and prodrug formulations.
With only 5 branded abuse-deterrent opioids on the market since the first one was approved in 2010, don't expect any generics to hit the market soon, RAPS says. Patents held by the brand-name drug companies could be a barrier to the generics' debut.
Dr. Douglas Throckmorton, deputy director for regulatory programs at the Center for Drug Evaluation and Research, said during the guidance's public introduction that that the agency "looks forward to a time when the majority of opioids on the market are ineffective, abuse-deterrent formulations," according to RAPS.
In February, the FDA said it would hold an advisory committee meeting for all new opioids that don't have abuse-deterrent properties. Despite several steps, including the guidance, designed to tackle the opioid abuse epidemic, questions remain.
During the remarks, FDA commissioner Dr. Robert Califf indicated that there is no clear policy or pathway for generic manufacturers who wish to add abuse-deterrent properties or achieve abuse-deterrent labeling to a generic version of an approved non-abuse deterrent opioid.
- here's RAPS' take
- read the guidance (PDF)